The purpose of this study is to determine if FDA approved food safety guidelines are equivalent to a low bacterial diet (the neutropenic diet) with respect to the acquisition of infections during neutropenia in a sample of pediatric cancer patients.
Historically, many interventions have been tried to reduce the incidence of infection by reducing patients' exposures to potential pathogens. The neutropenic diet is one such intervention that was intended to reduce the introduction of bacteria into the host's gastrointestinal tract. This diet excludes foods considered to be high risk for bacterial colonization, especially raw fruits and vegetables. The only studies evaluating this diet have used this intervention in combination with germ free environments, which have been phased out of practice, and the independent effect of this diet remains unknown. In addition, pediatric oncology patients suffer significant gastrointestinal side effects secondary to cancer therapy, which are likely to affect their satisfaction with this dietary regimen. Qualitative data in these children suggests that decreased pleasure from food is a major concern for them and preliminary data on the neutropenic diet showed that although patients were able to stick to it, they found it difficult. The Centers for Disease Control (CDC) and the Food and Drug Administration (FDA) offer more liberalized food safety guidelines for immunocompromised patients. We hypothesize that the neutropenic dietary restrictions offer no advantage over the FDA and CDC endorsed food safety guidelines and that the food safety guidelines will afford patients an improved quality of life through increased choice and control over their diet. The results of this study could potentially modify clinical practice to improve the quality of life of these patients without adverse effects on their rate of infection. Furthermore, the allowance of fresh fruits and vegetables back into the diets of these patients may have a positive impact on their health.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
149
Participants will be randomized to the food safety guidelines will receive information and recommendations regarding Food Shopping, Food Storage, Food Preparation, Safe Cooking, and Safe Serving of Food.
The Neutropenic Diet Guideline includes all information contained in the FDA Food Safety Guidelines with the addition of the following recommendations: 1. Avoid raw vegetables and fruit (Oranges and bananas are okay.) 2. Avoid take-out foods and fast foods and fountain drinks. 3. Avoid aged cheese (blue, Roquefort, Brie). 4. Cook all produce to well done. Eggs must be hard-boiled. 5. Avoid deli meats. 6. No raw nuts, nuts roasted in shell, or freshly ground nut butters from a health food store. 7. No well water 8. No yogurt
Rady Children's Hospital San Diego
San Diego, California, United States
Riley Hospital for Children at IU Health
Indianapolis, Indiana, United States
Maimonides Medical Center
Brooklyn, New York, United States
NYU Langone Medical Center
New York, New York, United States
Neutropenic Infection
Time frame: approximately 4 weeks
Documented Infection
Time frame: approximately 4 weeks
Quality of life
Time frame: Baseline and at study end
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Mount Sinai Medical Center
New York, New York, United States
Children's Hospital at Montefiore
The Bronx, New York, United States